Suture stitches for continuous surgical suturing

ABSTRACT

A suture stitch or a series of suture stitches with loops underneath and substantially parallel to the surface of a tissue for subcuticular suturing for reduced or minimized scarring and reduced suturing time. Each subsequent stitch connects with the previous suture through material across the diameter. The suture stitch or series of suture stitches include one or more knots acting as anchors for the first loop in the suture stitch or series of suture stitches, and the suture stitch or series of suture stitches are preferably administered via an automated suturing device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority from U.S.patent application Ser. No. 13/898,103, filed May 20, 2013, which is adivisional of and claims priority from U.S. patent application Ser. No.13/012,965, filed Jan. 25, 2011.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to surgical suturing methods and devices,and particularly to devices, machines, methods, needles, and stitchdesigns for cosmetic-grade suturing for reduced or minimized scarringand/or for organ or tissue internal suturing.

2. Description of the Prior Art

It is generally known in the prior art to provide specialized needlesand devices for suturing and for use with suture materials. Prior artpatent documents include the following: U.S. Pat. No. 67,545 issued Aug.6, 1867 for a spiral fissure needle; U.S. Pat. No. 196,226 issued Oct.16, 1877 for a corkscrew; U.S. Pat. No. 242,602 issued Jun. 7, 1881 fora corkscrew; U.S. Pat. No. 349,791 issued Sep. 28, 1886 for a sutureinstrument; U.S. Pat. No. 919,138 issued Apr. 20, 1909 for a surgicalneedle; U.S. Pat. No. 1,583,271 issued May 4, 1926 for a surgicalinstrument; U.S. Pat. No. 2,327,353 issued Aug. 24, 1943 for aninstrument for suturing; U.S. Pat. No. 2,959,172 issued Nov. 8, 1960 fora self-threading suture instrument; U.S. Pat. No. 3,037,619 issued Jun.5, 1962 for suture devices.

Also, it is known in the prior art to include a tubular needleconfiguration, such as in U.S. Pat. No. 4,204,541 issued May 27, 1980for a surgical instrument for stitching up soft tissues with lengths ofspiked suture material describes a surgical instrument for stitching upsoft tissues with lengths of spiked suture material that include ahollow body which houses a tubular needle having a through bore adaptedto accommodate said length of suture material to be introduced into thetissue being sutured along with the needle, and a stop stationary withrespect to the body and accommodated inside the through bore of theneedle. Both the needle and the stop are shaped as coils having the samediameter and lead, and the needle is mounted slidably along the stop soas to retain the length of suture material in the tissue being suturedwhile extracting the needle therefrom.

It is also provided in the prior art to provide suturing instruments,such as the following:

U.S. Pat. No. 4,440,171 issued Apr. 3, 1984 for a suturing instrumentand a method of holding a shuttle describes a surgical suturinginstrument that crosses and knots a suturing thread combining a shuttleand the other suturing thread passing through an eye of a curved needlein a lock stitching practice, for accomplishing smooth passage ofpassing the shuttle through a loop of the needle thread and exactcombination of the shuttle thread and the needle thread without gettingout the shuttle from a shuttle holder during the suturing operation soas to form sound suturing stitchings every time. The shuttle isaccommodated between a shuttle holder and a shuttle claw. The shuttle isformed with a front end portion movable between a guide groove in theshuttle claw and a guide groove in the shuttle holder. The shuttle isfurther formed with a sharp end for catching a thread loop in thesuturing operation.

U.S. Pat. No. 4,465,070 issued Aug. 14, 1984 for a stitching formationby a suturing instrument describes a suturing instrument used to formstitchings including stitching formation made by causing a shuttlethread to move in reciprocation on cut edges of a human part, betweenknottings and next knottings in a lock stitching, via an outer side of aneedle thread at a needle-out-hole from a needle-in-hole of a needle,thereby to make conglutination of the cut part stable and sound.

U.S. Pat. No. 4,524,771 issued Jun. 25, 1985 for a multiple curvedsurgical needle describes a needle which includes a plurality of curveswhich provide for improved control while suturing.

U.S. Pat. No. 4,641,652 issued Feb. 10, 1987 for a applicator for tyingsewing threads describes an applicator for utilization in combinationwith an endoscope tube includes a coil connected to a longitudinalpassage through a shaft and comprising hollow turns connected to theshaft passage for reception of a sewing thread, whose proximal extremityis passed through a loop projecting from a radial opening at the distalextremity of the shaft, is then drawn through the shaft passage andfastened to the proximal shaft extremity. Tying the single stitch afterpiercing the tissues is performed by passing the needle axially throughthe coil and then around the thread and twisting the coil out of theloop formed thereby to form the first half of a knot which is thencomplemented by the second half of the knot tied in the same way, theknot being tied by subsequently pulling together the two said halves.

U.S. Pat. No. 4,969,892 issued Nov. 13, 1990 for a suturing anchoringdevice for use in a female suspension procedure describes an anchoringmeans for anchoring a suture in tissue includes a housing, asubstantially cylindrical means within said housing for receiving asuture, and an adjusting means. Another anchoring means includes ahousing, a rotating spool within said housing, a driving gear, and anadjusting means.

U.S. Pat. No. 5,152,769 issued Oct. 6, 1992 for an apparatus forlaparoscopic suturing with improved suture needle describes a novelsuturing assembly defined by a new and improved suturing needle, havinga bore therethrough for forming an arc of thread to be grasped. Theassembly would comprise a first and second barrel portion, the portionsworking to allow a rod member to secure the arc of thread formed, andhold it in place, while the needle forms a second suture, and securesthe loop as part of the suture.

U.S. Pat. No. 5,356,424 issued Oct. 18, 1994 for a laparoscopic suturingdevice describes a laparoscopic suturing device that includes a suturingneedle and a driver for manipulating the needle.

U.S. Pat. No. 5,499,991 issued Mar. 19, 1996 for an endoscopic needlewith suture retriever describes a suture retriever and method formanipulating suture during endoscopic surgical procedures.

U.S. Pat. No. 5,507,743 issued Apr. 16, 1996 for a coiled RF electrodetreatment apparatus describes an RF treatment apparatus providesmulti-modality treatment for tumors and other desired tissue masses, andincludes an RF indifferent electrode and an active electrode.

U.S. Pat. No. 5,520,703 issued May 28, 1996 for a laparoscopic deschampand associated suturing technique describes a laparoscopic suturingdevice with an elongate shaft having a distal end and a proximal end andan arcuate tissue piercing element permanently fixed to the shaft at thedistal end, the arcuate tissue piercing element lying in a planedisposed substantially transversely to the shaft. The tissue piercingelement is provided at a free end, spaced from the shaft, with aneyelet, and the device has a suture thread extending through the eyelet.

U.S. Pat. No. 5,562,685 issued Oct. 8, 1996 for a surgical instrumentfor placing suture or fasteners and U.S. Pat. No. 5,709,692 issued Jan.20, 1998 for a surgical instrument for placing suture or fasteners at aremote location such as a laparoscopic surgery. The instrument is anelongated handle having a coiled projection at its distal end. Thecoiled projection is employed in penetrating and positioning a length ofsuture or fastener in tissue, for example, as in tissue proximation.

U.S. Pat. No. 5,810,851 issued Sep. 22, 1998 for a suture spring devicedescribes a guide used to position a suture spring device in anatomicaltissue in an elastically deformed, expanded state and is subsequentlyremoved to permit the suture spring device to move from the elasticallydeformed, expanded state toward a relaxed, contracted state to apply apredetermined compression to the tissue engaged by the device.

U.S. Pat. No. 5,911,689 issued Jun. 15, 1999 for a subcutaneousradiation reflection probe describes a subcutaneous radiation reflectionprobe for measuring oxygen saturation in living tissue includes anelongate drive shaft on one end of which is detachably coupled amounting cup.

U.S. Pat. No. 5,935,138 issued Aug. 10, 1999 for a spiral needle forendoscopic surgery describes a needle for endoscopic surgery is curvedinto an arc of more than 180.degree. And twisted, so that it forms apart of a spiral, with a lateral offset between the needle point andbarrel.

U.S. Pat. No. 5,947,983 issued Sep. 7, 1999 for a tissue cutting andstitching device and method describes a device for cutting tissue, thedevice comprising a first tube having a side window; a second tubepositioned within the first tube, the second tube having a side windowand being movable within the first tube; a third tube positioned withinthe second tube, the third tube having a side window and being movablewithin the second tube; and a needle insertable within the second tube,the needle housing a suture.

U.S. Pat. No. 6,113,610 issued Sep. 5, 2000 for a device and method forsuturing wound describes a needle assembly in which the needle isconstructed of a spring-like material and initially housed within asheath in a deformed condition. The needle can be easily exposed bysliding an actuator so as to release the constraining means and allowthe needle to assume its undeformed condition.

U.S. Pat. No. 6,520,973 issued Feb. 18, 2003 for an anastomosis devicehaving an improved needle driver describes an anastomosis device forattaching a first hollow vessel to a second hollow vessel. The deviceincludes a handle for holding the device, and a head assembly, attachedto the handle, for holding the first and second hollow vessels adjacentto each other. The head assembly having a distal end, a proximal end anda longitudinal axis there between. The device further includes a needleguide disposed longitudinally along the head assembly adjacent to thevessels, and a helical needle, having a suture attached to a proximalend thereof, disposed within the head assembly at its proximal end. Thedevice has an actuator on the handle for actuating a needle driver. Theneedle driver is coupled to the head and includes a flexible rotatablemember operated by the actuator, for rotating and driving the needledistally along the needle guides and through the first and second hollowvessels.

U.S. Pat. No. 6,537,248 issued Mar. 25, 2003 for a helical needleapparatus for creating a virtual electrode used for the ablation oftissue describes a surgical apparatus for delivering a conductive fluidto a target site for subsequent formation of a virtual electrode toablate bodily tissue at the target site by applying a current to thedelivered conductive fluid. The surgical apparatus includes an elongateddevice forming a helical needle.

U.S. Pat. No. 6,562,052 issued May 13, 2003 for a suturing device andmethod that allows a physician to remotely suture biological tissue.

U.S. Pat. No. 6,613,058 issued Sep. 2, 2003 for an anastomosis devicehaving needle receiver for capturing the needle after it has passedthrough the needle guide.

U.S. Pat. No. 6,626,917 issued Sep. 30, 2003 for a helical sutureinstrument which either pushes or pulls a suture along a helical needletract.

U.S. Pat. No. 6,663,633 issued Dec. 16, 2003 for a helical orthopedicfixation and reduction device, insertion system, and associated methodsdescribes a system for fixation of a soft tissue tear includes aflexible, generally helical fixation element biased to a predeterminedpitch and a hollow, generally helical insertion element dimensioned toadmit at least a distal portion of the fixation element into a lumenthereof.

U.S. Pat. No. 6,723,107 issued Apr. 20, 2004 for a method and apparatusfor suturing describes devices and techniques for suturing that areparticularly useful in laparoscopic, arthroscopic, and/or open surgicalprocedures. A method of delivering a suture includes providing a suturedevice, releasably coupling a suture to a distal end of a suture deviceby threading the suture through a first region of a bounded opening ofthe suture device and moving the suture to a second region of thebounded opening having a dimension smaller than a diameter of the sutureto trap the suture in the second region, penetrating a substrate withthe distal end of the suture device such that the a portion of thesuture passes through the substrate, and releasing the suture from thedistal end of the suture device.

U.S. Pat. No. 6,911,003 issued Jun. 28, 2005 for transobturator surgicalarticles and methods describes surgical articles, implants andcomponents suitable for a transobturator surgical procedure.

U.S. Pat. No. 6,911,019 issued Jun. 28, 2005 for a helical needleapparatus for creating a virtual electrode used for the ablation oftissue describes a surgical apparatus for delivering a conductive fluidto a target site for subsequent formation of a virtual electrode toablate bodily tissue at the target site by applying a current to thedelivered conductive fluid.

U.S. Pat. No. 6,911,037 issued Jun. 28, 2005 for a retrievable septaldefect closure device describes a septal defect closure device having afirst occluding disk having a first flexible membrane attached to afirst frame and a second occluding disk having a second flexiblemembrane attached to a separate second frame. The first frame has atleast two outwardly extending loops joined to one another by flexiblejoints. These loops are attached to the first membrane to define tautfabric petals when the first disk is in a deployed configuration.

U.S. Pat. No. 6,923,807 issued Aug. 2, 2005 for a helical device andmethod for aiding the ablation and assessment of tissue describes ahelical needle attached to a surgical probe to aid in the insertion ofthe probe into a tissue mass.

U.S. Pat. No. 6,986,776 issued Jan. 17, 2006 for a suturing apparatus,method and system describes an apparatus used with a helical suturedevice has a first end and a second end. The first end includes aspatulate member having a length along a first axis. The second endincludes a guide shaped to receive a cylindrical axle of the helicalsuture device for rotation on a second axis. The guide is shaped toconstrain the first axis in fixed position relative to the second axis,the first and second axes each lying within a plane. The spatulatemember extends, typically symmetrically, in a first direction and asecond direction from the first axis, the first direction and seconddirection being on opposite sides of the plane. The apparatus liesbetween a first tissue that is to be sutured, and a second tissue thatis desired not to be sutured.

U.S. Pat. No. 7,070,556 issued Jul. 4, 2006 for transobturator surgicalarticles and methods describes a surgical instrument and method fortreating female urinary stress incontinence. The instrument includes afirst curved needle-like element defining in part a curved shaft havinga distal end and a proximal, a mesh for implanting into the lowerabdomen of a female to provide support to the urethra; a second curvedneedle element having a proximal end and a distal end, and a coupler forsimultaneous attachment to the distal end of the first needle and thedistal end of the second needle.

U.S. Pat. D543,626 issued May 29, 2007 for a handle for a surgicalinstrument describes an ornamental design for a handle for a surgicalinstrument

U.S. Pat. No. 7,235,087 issued Jun. 26, 2007 for an articulatingsuturing device and method describes devices, systems, and methods forsuturing of body lumens allow the suturing of vascular puncture siteslocated at the distal end of a percutaneous tissue tract.

U.S. Pat. No. 7,269,324 issued Sep. 11, 2007 for a helical fiber opticmode scrambler describes methods and apparatus of the present inventionprovide advantages for remote laser delivery systems that conduct highlevels of light energy through a fiber optic cable to a selectabletarget surface.

U.S. Pat. No. 7,288,105 issued Oct. 30, 2007 for a tissue openingoccluder describes a tissue opening occluder including first and secondoccluder portions, each occluder portion including a frame structure andan attachment structure to attach one portion to the other portion. Theframes may be utilized to constrain the tissue between the two portionsenough to restrict the significant passage of blood therethrough.

U.S. Pat. No. 7,290,494 issued Nov. 6, 2007 for a method formanufacturing stent-grafts describes a sewing machine which is capableof sewing reinforcing wire to tubular grafts in order to form stentgrafts. A bobbin (which may be seated in a shuttle) carries a bottomthread through the bore of the tubular graft and forms a stitch incombination with a top thread carried on a needle which pierces thegraft wall.

U.S. Pat. No. 7,309,325 issued Dec. 18, 2007 for a helical needleapparatus for creating a virtual electrode used for the ablation oftissue describes a surgical apparatus for delivering a conductive fluidto a target site for subsequent formation of a virtual electrode toablate bodily tissue at the target site by applying a current to thedelivered conductive fluid.

U.S. Pat. No. 7,323,004 issued Jan. 29, 2008 for a device for providingautomatic stitching of an incision describes an automatic suturingdevice including: a body for insertion into an opening in tissue; aplurality of hooks movably disposed in the body between retracted andextended positions; a suture holder having sutures disposed therein, thesuture holder having a mechanism for engaging a portion of the hookswhen in the retracted position and for attaching the sutures to aportion of the plurality of hooks; and an actuator for actuating theplurality of hooks from the retracted position to the extended positionand for embedding the exposed plurality of hooks with the attachedsutures into the tissue surrounding the opening.

U.S. Pat. No. 7,335,221 issued Feb. 26, 2008 for a suture anchoring andtensioning device and method for using same describes a suture anchoringdevice made from a coiled member having a helical configuration with amultiplicity of turns. When used in connection with a surgicalprocedure, the device is positioned adjacent to a wound site and asuture is attached to at least two of the turns so as to anchor thesuture to the coiled member.

U.S. Pat. No. 7,347,812 issued Mar. 25, 2008 for prolapse repairinstruments.

U.S. Pat. No. 7,351,197 issued Apr. 1, 2008 for a method and apparatusfor cystocele repair describes comprising the steps of: establishingfour pathways in tissue around a bladder of a patient, introducing astrap into each of said pathways, and positioning beneath said bladderof said patient a support member having each said strap connectedthereto such that said bladder of said patient is supported by saidsupport member and a bulge of said bladder into a vagina of said patientis reduced.

U.S. Pat. No. 7,357,773 issued Apr. 15, 2008 for a handle and surgicalarticle describes handles for needles suitable for pelvic floor surgicalprocedures.

U.S. Pat. No. 7,371,244 issued May 13, 2008 for a deployment apparatusfor suture anchoring device describes a deployment device for anchoringa suture to a suture anchoring device, which is made from a helicallycoiled member, includes a winding tube for winding a suture around thecoiled member in a helical path such that the suture is attached to atleast one turn of the coiled member.

U.S. Pat. No. 7,377,936 issued May 27, 2008 for a retrievable septaldefect closure device describes a septal defect closure device having afirst occluding disk having a first flexible membrane attached to afirst frame and a second occluding disk having a second flexiblemembrane attached to a separate second frame. The first frame has atleast two outwardly extending loops joined to one another by flexiblejoints. These loops are attached to the first membrane to define tautfabric petals when the first disk is in a deployed configuration.

U.S. Pat. No. 7,479,155 issued Jan. 20, 2009 for a defect occluderrelease assembly and method describes a release assembly is provided toaid the reversible and repositionable deployment of a defect occluder.The release assembly includes an occluder tether having a distal portioncomprising at least one suture loop, and a snare structure having adistal portion comprising a snare element. The at least one suture loopis receivable through at least a portion of the defect occluder, andreversibly looped over an anchor element so as to permit reversiblecollapse the defect occluder for selective ingress and egress from adelivery catheter. The snare element is reversibly engageable with theanchor element so as to reversibly retain the at least one suture loopupon the anchor element, and thereby hold the defect occluder in aposture for reversible free-floating tethered deployment in a defectwhile being observable in a final position prior to release.

U.S. Pat. No. 7,500,945 issued Mar. 10, 2009 for a method and apparatusfor treating pelvic organ prolapse describes the steps of establishing afirst pathway between the external perirectal region of the patient tothe region of the ischial spine in tissue on one side of the prolapsedorgan, followed by establishing a second pathway in tissue on thecontralateral side of the prolapsed organ. A support member, whichincludes a central support portion and two end portions, is positionedin a position to reposition said prolapsed organ in said organ'sanatomically correct location. The end portions of the support memberare introduced through the respective tissue pathways, followed byadjustment of the end portions so that the support member is located ina therapeutic relationship to the prolapsed organ that is to besupported.

U.S. Pat. No. 7,582,103 issued Sep. 1, 2009 for a tissue openingoccluder describes a tissue opening occluder comprising first and secondoccluder portions, each occluder portion including a frame structure andan attachment structure to attach one portion to the other portion. Theframes may be utilized to constrain the tissue between the two portionsenough to restrict the significant passage of blood therethrough.

U.S. Pat. No. 7,588,583 issued Sep. 15, 2009 for a suturing device,system and method describes improved medical suturing devices, systems,and methods to hold a suture needle at a fixed location relative to ahandle of the device, allowing the surgeon to grasp and manipulate thehandle of the suturing device to insert the needle through tissues in amanner analogous to use of a standard needle gripper.

U.S. Pat. No. 7,637,918 issued Dec. 29, 2009 for a helical suturingdevice describes an apparatus for repairing a tear in an annulusfibrosus of a spinal disc includes a hollow, helically-shaped suturingneedle and a retriever.

U.S. Pat. No. 7,686,821 issued Mar. 30, 2010 for a apparatus and methodfor positive closure of an internal tissue membrane opening describes adevice having two components: a needle advancing apparatus slidablelongitudinally along a catheter to advance needles into a tissuemembrane, such as a blood vessel wall, around an opening in themembrane; and, a suture retrieval assembly insertable through thecatheter beyond a distal side of the tissue membrane.

U.S. Pat. No. 7,699,805 issued Apr. 20, 2010 for a helical coilapparatus for ablation of tissue describes a surgical apparatus fordelivering a conductive fluid to a target site for subsequent formationof a virtual electrode to ablate bodily tissue at the target site byapplying a current to the delivered conductive fluid.

U.S. Pat. No. 7,699,857 issued Apr. 20, 2010 for a hydrodynamic suturepasser describes a hydrodynamic suturing instrument, comprises aelongated cannulated suturing needle having a distal end configured tocarry a suture through tissue and a proximal end adapted to connect to asyringe barrel and a lumen extending from said proximal end to anopening at the distal end for having a size for the passage of a suture,and the opening at the distal end configured to receive a sutureextending from the lumen along an outer surface of the needle wherein asharp point extends forward of the suture. A companion instrumentincludes forceps having a distal end with jaws and a proximal end with alumen extending from the proximal end to the distal end for passage ofthe needle, and the jaws having an opening enabling passage of theneedle through tissue grasped in the jaws.

U.S. Pat. No. 7,699,892 issued Apr. 20, 2010 for a minimally invasiveprocedure for implanting an annuloplasty device describes a method formodifying a heart valve annulus includes placing a purse string sutureat a puncture site adjacent a heart valve, inserting at least onedelivery member through the puncture site, positioning a distal end ofthe at least one delivery member adjacent a portion of a valve annulus,deploying an annuloplasty device carried within the at least onedelivery member and implanting the annuloplasty device into the valveannulus. The method also includes reshaping the heart valve annulusafter implantation of the at least one annuloplasty device.

U.S. Pat. No. 7,776,059 issued Aug. 17, 2010 for a suturing methoddescribes an apparatus used with a helical suture device has a first endand a second end. The first end includes a spatulate member having alength along a first axis. The second end includes a guide shaped toreceive a cylindrical axle of the helical suture device for rotation ona second axis. The guide is shaped to constrain the first axis in fixedposition relative to the second axis, the first and second axes eachlying within a plane. The spatulate member extends, typicallysymmetrically, in a first direction and a second direction from thefirst axis, the first direction and second direction being on oppositesides of the plane. The apparatus lies between a first tissue that is tobe sutured, and a second tissue that is desired not to be sutured.

U.S. Pat. No. 7,780,700 issued Aug. 24, 2010 for a patent foramen ovaleclosure system describes a patent foramen ovale closure device, methodof delivering and a delivery system are provided. The device may includea closure device releasably connectable to an actuator. The device mayinclude a proximal segment, an intermediate segment and a distalsegment. When delivered, the proximal segment and intermediate segmentform a first clip-shaped portion sized and configured to be positionedover a septum secundum of the patent foramen ovale, and the intermediatesegment and distal segment form a second clip-shaped portion sized andconfigured to be positioned over a septum primum of the patent foramenovale.

U.S. Pat. No. 7,794,471 issued Sep. 14, 2010 for a compliant anastomosissystem describes an integrated anastomosis tool may include an effectorthat both makes an opening in the wall of a target vessel and connects agraft vessel to the target vessel. The connection between the graftvessel and the target vessel may be compliant, and may be achieved bydeploying a plurality of connectors such as staples into tissue.

SUMMARY OF THE INVENTION

The present invention relates to suturing methods and devices, includingmachines, needles, and methods of using them, and also for the stitchesproduced thereby, for suturing with reduced or minimized scarring, andthat is especially useful for cosmetic-grade suturing applications andreducing suturing time.

It is an object of this invention to provide a machine constructed andconfigured for automatic suturing for reduced or substantially minimizedscarring and reducing suturing time.

It is an object of this invention to provide methods for using a machineoperable for automatic suturing for reduced or substantially minimizedscarring and reducing suturing time.

Yet another object of this invention is to provide a needle designed andconstructed for suturing, and more particularly for use with a machineoperable for automatic suturing for reduced or substantially minimizedscarring and reducing suturing time.

A further object of this invention is to provide a variety ofalternative embodiments for needles designed and constructed forsuturing, and more particularly for use with a device and/or a machineoperable for automatic suturing for reduced or substantially minimizedscarring and reducing suturing time.

Still another object of the present invention is to provide a continuousconnection of loops forming a suture stitch for suturing with reduced orsubstantially minimized scarring and reducing suturing time.

These and other aspects of the present invention will become apparent tothose skilled in the art after a reading of the following description ofthe preferred embodiment when considered with the drawings, as theysupport the claimed invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view diagram of the main components of the headof a device for suturing showing skin subcuticular suturing embodimentof the invention.

FIG. 2 is a perspective view diagram illustrating the head of a devicefor suturing according to one embodiment of the invention.

FIG. 3 shows a perspective view diagram illustrating a portion of anautomated machine for suturing from FIG. 1 focused on the hook andneedle interaction for forming continuous suture stitches according toone embodiment of the invention.

FIGS. 3A-J illustrate perspective view diagrams of the portion of theautomated machine of FIG. 1 shown in various positions of operation fora single cycle completing a stitch in suturing automated by the machineof the present invention.

FIG. 4 shows the offset subcuticular skin suturing mechanism of FIG. 1.with the tip of the helico-spiral needle in the home position (outsidethe skin)

FIG. 5 shows the offset subcuticular skin suturing mechanism of FIG. 1.with the tip of the helico-spiral needle in its final position aftercompleting one skin bite.

FIG. 6 shows a top view diagram illustrating a stitching pattern for asingle unit cycle for making continuous suturing made by an automatedmachine for suturing according to one embodiment of the invention.

FIGS. 7A-C illustrate in perspective views three alternatives forcontinuous suture stitching forming chains of single unit cyclesillustrated from FIG. 6

FIGS. 8A-C shows three perspective views each illustrating a solidneedle in alternative embodiments for use in suturing according to thepresent invention.

FIGS. 9A-C shows three perspective views each illustrating a hollowneedle in alternative embodiments for use in suturing according to thepresent invention.

FIGS. 10A-C shows three perspective views each illustrating a hook inalternative embodiments for use with an automated machine for suturingof the present invention.

FIGS. 11A and 11B are tables of commercial suture materials and priorart needle references.

FIGS. 12A-F are images of commercial suture needle information.

DETAILED DESCRIPTION

The present invention provides a device constructed and configured forautomatic suturing for reduced or minimized scarring, reducing suturingtime and methods for using a machine operable for automatic suturing.Additionally, the present invention provides a variety of needles,designed and constructed for suturing to minimize or eliminate scarring,reducing suturing time and more particularly for use in combination withhooks for making a continuous suture stitch with a machine operable forautomatic suturing for reduced or minimized scarring, reducing suturingtime.

As set forth herein, the present invention provides machines, methodsand needle designs for automatic suturing with minimum scarring andreducing suturing time. Referring now to the drawings in general, theillustrations are for the purpose of describing a preferred embodimentof the invention and are not intended to limit the invention thereto.

FIG. 1 is a perspective view diagram of the main components of the headof a device for suturing showing skin subcuticular suturing embodimentof the invention.

FIG. 2 is a perspective view diagram illustrating the main components ofthe head of a device for suturing according to one embodiment of theinvention. FIG. 3 shows a perspective view diagram illustrating aportion of the main components of the head of a device for suturing fromFIG. 2 focused on the hook and needle interaction for forming continuoussuture stitches according to one embodiment of the invention. The suturemachine is generally referenced 10, and includes at least the followingcomponents constructed and configured in operable connection forautomatically producing a stitch: a support base or housing 12, a suturethread supply (not shown) having a first end and a second end, removably(movable) mounted on the support base via a connecting cylindrical post(not shown), a substantially spiral-shaped hollow needle 18 movablerotationally between a first (home position) and second position forforming a stitch, and a hook 20 (FIG. 3) movable between a retracted 22and an extended position (23, FIG. 3D, closer toward the needle tip thanthe retracted position, 22) by an automated gear device (not shown). Themachine for making suture stitches automatically according to thepresent invention preferably includes a machine body or base forsupporting or otherwise connectable to a suture thread supply, a needleconstructed and configured for receiving and manipulating a first end ofthe suture thread supply, wherein the needle is rotationally movable sothat a needle tip advances between a first and second position foradjoining at least two edges for continuously stitching them together ina substantially edge-to-edge interface without overlapping the edges,aided by a wound separator mounted on or part of the machine body 12ahead of the suture line (the wound separator is not shown) therebyproviding an automated device for making suture stitches that produceminimal scarring on tissue, organs, or skin. The wound separator is toprevent wound overlapping.

In an automated machine for suturing according to an alternativeembodiment of the present invention from FIG. 2, note that the hookdevice mechanism may be constructed and configured to be in an angledposition; preferably, the hook device mechanism is adjustable, but inany position, the hook is always configured to be in parallel to thespiral needle. However, overall components and functionality aresubstantially similar to the foregoing description, but the angledpositioning of these components is preferred for forming a “sideways”suture using a helical needle. The angle of the spiral needle axis inrelation to the surface of the tissue to be sutured is preferablyadjustable between about 10 degrees and about 90 degrees, wherein 90degrees angle is perpendicular to the wound or tissue surface where thesuturing is made (i.e., the suturing zone), preferably between about 25and about 90 degrees, and more preferably between about 45 and about 90degrees. The application and type of suture are factors affecting theangle. The angles provide for creating hidden sutures and in the use ofsuturing fascia, muscles, or hollow organs, such as the intestines,wherein the skin adjoined by the sutures is substantially or perfectlyflat, and without overlap, thereby minimizing scarring.

FIG. 2 is a perspective view diagram illustrating the head of a devicefor suturing according to one embodiment of the invention.

FIG. 3 shows a perspective view diagram illustrating a portion of anautomated machine for suturing from FIG. 2 focused on the hook andneedle interaction for forming continuous suture stitches according toone embodiment of the invention.

FIGS. 3A-J illustrate a perspective view diagram of the portion of theautomated machine of FIG. 3 shown in various positions of operation fora single cycle completing a stitch in suturing automated by the machineof the present invention.

FIG. 3 shows a perspective view diagram illustrating a portion of anautomated machine for suturing according to one embodiment of theinvention. Furthermore, FIGS. 3A-J illustrate a perspective view diagramof the portion of the automated machine of FIG. 3 shown in variouspositions of operation for a single cycle completing a stitch insuturing automated by the machine of the present invention. By movingthrough this cycle automatically, a hook 20 is moved by a rotating gear(not shown) between a first retracted position (FIG. 3A) after catchinga loop 34 made with the suture thread that is picked up next by aholding arm 36 that moves forward as in positions B, C, D, and E toallow the hook to move into a second extended position to release theloop and then move to catch the next loop (if any, depending on thelength of the chain of stitches) illustrated in F and G positions. Inthis method, the suture stitch is formed of a series of interconnectedloops (single stitch unit cycle is illustrated in FIG. 6; continuousseries illustrated in FIGS. 7A-C) by the cooperation, coordination andsynchronization of the needle and hook components to effectively knitthe suture stitches into a connected chain that is continuous andsubstantially planar.

Methods for making suture stitches automatically according to thepresent invention include the steps of: providing a machine having asuture thread supply, a needle constructed and configured for receivingand manipulating a first end of the suture thread supply, rotationallymoving the needle and thread to create a suture stitch by advancing theneedle position, and adjoining at least two edges for continuouslystitching them together in a substantially edge-to-edge interface,thereby making suture stitches that produce minimal scarring on tissue,organs, or skin and reducing suturing time.

In preferred methods, the step of moving the needle rotationally tocreate a suture stitch is automatically made, by activating the machineto move the needle to create a first rotational part of the stitch,introducing a hook in a retracted position to catch the stitch at theend of the rotational movement, reversing the direction of rotation ofthe needle, moving the hook to a second extended position and releasingthe stitch, and extracting the needle to complete the stitch. After theneedle and hook form a single stitch, or a series of connected stitches,depending upon the size of the suture area, preferably the suture threadwill be cut, by scissors, or other sharp utensil. Additional cuttingmechanism (not shown) can be added to the body of the machine such as avertical blade retracted in a groove in the body of the machine. Suchblade has a distal sharp flat end and blunt proximal end. The distal endis close to the stitch loop when such loop is pulled up by the hook in aretracted position inside the body of the machine. The proximal end isconnected to a spring loaded button that is operated manually by thesurgeon. At the end of the suture line, the surgeon can go back andforth with continuous suturing to ensure the security of the suture end.Then the surgeon pushes the button, which in return pushes the rod downto let the distal sharp flat end cut the suture material and to end thecontinuous line of suturing.

FIG. 6 shows a top view diagram illustrating a stitching pattern for asingle unit cycle for making continuous suturing made by an automatedmachine for suturing according to one embodiment of the invention.

FIGS. 7A-C illustrate in perspective views three alternatives forcontinuous suture stitching forming chains of single unit cyclesillustrated from FIG. 6.

A suture stitch single unit cycle formed from the method describedhereinabove is illustrated in FIG. 6, and in FIGS. 7A-C it is shown inone continuous suture stitch chain embodiment formed from a series ofinterconnected stitches by repeating the foregoing steps: FIG. 7A shows5 units repeated and in a spaced apart manner so that the circularportion of the stitch unit cycle does not directly touch or is notdirectly juxtapositioned another stitch unit cycle; FIG. 7B shows 7units repeated that are directly touching, i.e., the circular portion ofthe stitch unit cycle is formed and positioned so that it is directly orapproximately directly juxtapositioned the next stitch unit cycle; FIG.7C shows 5 stitch unit cycles wherein the circular portion of each unitcycle is overlapping with an adjacent stitch unit circular portion. Themethod of forming the stitch includes rotational movement of the needlevia rotation of a shaft along its axis. Then parallel to the needleshaft (shown in FIG. 3), a hook catches the loop formed by the suturethread from the rotational needle movement (before or just after theneedle reverses direction) and the hook pulls the loop out of the plane,as illustrated in FIG. 3 and FIG. 3 views, for forming a chain orcontinuous connection of a series of loops formed by the needle movementof the suture thread (single stitch unit cycle illustrated in FIG. 6;continuous suture stitching embodiments illustrated in FIGS. 7A-C).

FIGS. 8A-C shows three perspective views each illustrating a solidneedle in alternative embodiments for use in suturing according to thepresent invention.

FIGS. 9A-C shows three perspective views 9A (spiral needle), 9B(helico-spiral needle), and 9C (helical needle) each illustrating ahollow needle in alternative embodiments for use in suturing accordingto the present invention.

For a spiral needle as in FIG. 8A or FIG. 9A, or for the helico-spiralneedle FIG. 8B or 9B, the hook is positioned preferably at 90 degreeangle to the needle. For a helical needle, as illustrated in FIGS. 8C,9C, the hook is preferably positioned at an angle with respect to theneedle. For using a latch hook as in FIG. 10A, the process is notentirely dissimilar from knitting methods for creating a continuouschain of loops; however, an alternative embodiment for the machine isrequired (completely different from knitting machines and methods,requiring an additional catcher mechanism) when using a non-latch hookas illustrated in FIGS. 10B and 10C; in preferred embodiments, theshorter hook of FIG. 10B is used.

As illustrated in the figures, the present invention and machine andmethods of using same further include a spiral-shaped suture needle formaking suture stitches wherein the suture needle includes a continuouslyhollow needle body having a first end positioned a spaced apart distancefrom a second pointed, sharp end, wherein the needle body forms a spiralhaving at least two complete turns around a center point, wherein thesecond end is positioned at the outermost spiral. FIGS. 9A-C providethree perspective views, each illustrating a needle in alternativeembodiments for use in suturing and for use with an automated machinefor suturing of the present invention. The needle body is an elongatedmetal cylinder that is formed and configured to be spiraled for formingthe stitch for suturing in an edge-to-edge manner without substantialoverlapping of the tissue, skin or organ. The important dimensions forthe needle are the diameter; the height is a secondary dimensionconsideration. For a hollow needle, the needle tube outer diameter ispreferably between about 1 mm and about 3 mm; more preferably betweenabout 1 mm to about 2 mm. The needle spiral dimension is between about 5mm to about 25 mm; more preferably between about 5 mm and about 15 mm.For the solid needle, the same outer diameter and the needle spiraldimension apply. The dimensions for the needle depend upon the type andsize of suture thread, type and nature of tissue being connected withthe suture (e.g., facial skin would require a finer needle with smallerdimensions), and other factors, including whether it is an open wound orinside the body, the size and dimensions of the device or machine, andthe like. Also, the length of the needle is dependent upon the number ofcoils in the spiral, which is a function of the application, or the typeof suture thread, type of tissue being connected with the suture, etc.

By way of example, typically used for the skin, 5/0 monocryl suture, theneedle will have outer diameter of 0.36 mm and curvature of 11 mm. Forfascia, muscles, and internal organs, such as intestines, larger sizesutures from 4/0 up to about #2 would require much larger needle andcurvature. Smaller sizes would be used for microsurgery, and eyesurgery.

In one embodiment, preferably the second pointed sharp end is angled toexpose an ovular opening of the needle body. Such opening is preferredto have smooth rounded edges to allow the suture material to slideeasily with minimal friction especially if used with the hollowhelico-spiral needle. Preferably the suture needle further includes anopening spaced apart from the second pointed sharp end of the needle forforming the suture stitch and to allow the suture thread to exit at theside or edge of the tissue. A latch needle or spring needle or hybrid ofboth may be used with machines of the present invention. Steps formethods of using these needles with or without the machines of thepresent invention include: inserting the needle at the point or locationfor the first suture stitch; catching the suture stitch with the hook;pulling out the needle by reversing its rotation; the hook releasing theloop; holding the loop by the catcher, hooking the next loop by the hookand pulling it through the previous suture stitch loop (illustrated bythe positions of machine components in FIGS. 3A-G) to form asubstantially parallel series of continuous loops along the suturetissue line. In a significant difference from knitting known in theprior art, the stitching of loops for forming the sutures of the presentinvention are formed in a single flat line and only connected on asingle side of the loop of the stitches, as illustrated in FIG. 6.

FIG. 6 illustrates a view showing single side loops that are connected.

The bottom loop goes through the opposing side loop for interconnectingand closing the wound from both sides. These illustrations in thefigures provide step by step methods for making the suture according tothe present invention, and also show the device and/or machine componentpositioning and configuration at each step. Depending upon where thenext stitch entry is made determines the pattern and closure for thesuture stitch; three embodiments of suture stitch chains areillustrated, from spaced apart non-interlacing or overlapping loops(FIG. 7A); to another view showing adjacent loops that arejuxtapositioned but not overlapping (FIG. 7B); and a third view showingoverlapping or interlacing loops or stitches (FIG. 7C). In each exampleembodiment, a perspective view is shown.

In preferred embodiments, it is better to stretch the stitch longer,i.e., to make the circular loops stretched (each loop circle isstretched longer); it is helpful for the purposes of this detaileddescription of the invention to consider each loop as a unit cell.Depending on a link from each end of the unit cell, determines howtightly each unit cell is positioned. Each entry into theskin/tissue/organ is more distantly spaced apart.

FIGS. 8C, 9C show a perspective views for one of the suture needleconfigurations, although it is not preferred, since there are too manycoils, which makes more friction for the suture inside. It would bepreferred to place the suture outside that needle when it is used.

FIGS. 8A, 9A show another compact view of a needle embodiment of thepresent invention; however, it is likewise not the preferred embodiment,because when the needle starts to rotate, there is still a need tosqueeze the wound to press together the wound edges to be stitched.Position of hook would be straight for A, which is acceptable, but notpreferred.

FIGS. 8B, 9B are preferred needle types (solid more preferred thanhollow) and illustrates a hybrid between 9A and 9B because some part ofthe spiral shape with helical, but not completely conical; it is insteadfrom spiral to helical, and is the preferred needle embodiment—thehelical-spiral (or helico-spiral) hybrid needle.

A compact device embodiment is preferred, wherein the last circle of theneedle component is spiral, with two helical and last one on bottom isspiraled out wider; the latch needle is positioned to be operable in avertical up and down movement. In methods preferred and illustrated inthis figure, steps are included to catch the loop from both sides sothat a catch makes a loop of the suture on both sides; on one cyclethere is a catching mechanism to catch from left side; then a step topull the latch mechanism up; then a step to retract the spiral needle;then the catcher and the latch needle (hook) work together to catch theloop on the other side, so it goes through first loop and pulls throughthe second loop, and each time comes from one side of the wound. Onetime it is at an acute angle; one time straight.

By way of preferred embodiment for an example or prototype of thepresent invention, a solid needle is provided with helical-spiral shape.While a hollow needle is possible, at the time of the invention example,it is practically easier to make a device according to the presentinvention with a solid needle. One reason is that it is easier to pullout the suture to make the wound tighter; another is that it is alsoeasier to use a solid needle in combination with a spring-based orlever-based tensioner or tension-providing mechanism. A commercialreason for preferring a solid needle instead of a hollow needleconfiguration is that the hollow needle is more expensive to produce.Also, there is some difficulty threading it, and in operation, there isadditional friction and tension in the needle since the suture threadpasses through and contacts the needle's internal surfaces in thishollow needle configuration. For these reasons, in the preferredembodiments at the time of the present invention, non-hollow needlecomponents are used in prototype experimentation.

Note that in FIG. 3 and the various FIGS. 3A-J, all illustrations showthe continuous suture stitch beginning with a knot. Now regarding theillustrations of FIG. 3 and FIGS. 3A-J, starting from position zero inthe formation of a single suture stitch unit cycle the steps are asfollows:

Position zero. The hook is positioned up; the catcher has a multiplicityof positions, preferably with 3 positions: home, catch, and pushpositions that are illustrated in the various figures. The catcher hooksthe loop when the catcher is positioned in a second position, and it isalso hooked on the loop at that time. Two alternatives are considered inprototype versions of the embodiments of the present invention that usea vertical needle: 1) go through the loop exactly; and/or 2) go throughthe loop and past it. If the first alternative is used, then the methodsfor making sutures according to and with the device and machineaccording to the present invention provide for the following steps:pushing the suture to that position to make a space for the hook to goexactly through the loop. In this step, it is very important for safetythat there be adequate space for the hook to move exactly through theloop, otherwise it is possible to lose at least one stitch in the nextor following step(s). The suture goes through the hole in the helicalspiral hybrid needle and through the tube (in the case of a hollowneedle embodiment) up to the spool. In a prototype version according toone embodiment of the present invention, the suture goes through needleand through body on the right side for pulling the suture with anadditional mechanism. Again, for commercial application, the solid ornon-hollow needle is preferred over use of application of hollow needleconfiguration since the hollow needle is expensive to produce, there issome difficulty threading it, and there is additional friction andtension in the needle during its use in methods of the presentinvention, since the suture thread passes through and contacts theneedle's internal surfaces in this hollow needle configuration. Forthese reasons, in the preferred embodiments at the time of the presentinvention, non-hollow needle components are used in prototypeexperimentation.

Again, referring to the method steps illustrated in FIG. 3 and FIGS.3A-J. Once the final position zero is returned to, a single unit cell orunit cycle is completed.

Position 1. For the next bite or next step in forming a continuoussuture stitch chain as illustrate in the Figures: shift the entiremechanism forward. The way the mechanism shifts and how the suture goesfrom the helico-spiral needle and pulls the loop held by the verticalhook. If additional tension or pull is provided on the loop, it makesthe wound tighter.

Position 2. First bite or needle entry into the wound. Hole in needlenear tip or sharp end to show how the suture thread or suture materialexits the needle and goes to tensioning device.

Position 3. Rotation is 45 degrees from p1 to p2. This is now 360degrees rotation. Radius of needle is smaller than the first rotationfrom the tip of the needle b/c spiral.

One suture all the way up; 2d goes through the wound.

The figures also show stitched loops with reference to left side ofwound; right side of wound.

Next the final position of the helico-spiral needle before catching thesuture is shown.

Catcher pushes the loop from the hook. The vertical needle hook islower; catcher pushes the loop & holds it in a position. At that pointthe hook starts moving down exactly through the loop because it's heldin 2 directions horizontal and vertical to assure that one loop goesthrough another; this is critical in the methods of the presentinvention.

After that hook goes through the lower position, close to thehelico-spiral needle to ensure that the hook passes through the spacebetween the suture and the helico-spiral needle to be ready to catch theloop.

At the bite, it is from the front side of the loop. When the needlerotates, diagram 3D, the needle is positioned below the loop. Thehelico-spiral needle rotates backwards 45 degrees and the vertical hookcaptures the next suture, and then pulls out the next loop. The priorloop is inside of the helico-spiral needle.

The new loop is pulled through the prior loop. Next the vertical hook ispositioned up; pusher retracts. Before retracting catcher to right, thevertical hook is pulled up. Then retract the catcher. The chain is nowmade forming the circular portion for the continuous suture stitch. Nextthe catcher moves or is pushed to catch the next loop (the new loop).

Then go to or return to position zero (0).

The method steps are focused on one bite at a time for these steps inthe exploded partial views of the FIGS. 3, 3A-J.

Note that these diagrams are all indicated as being oriented to thewound without angle. It could be vertical for skin. If muscles or otherorgans, it may be 45 degree angle. In the skin, you take bites parallelto skin. For muscles, fascia or internal organs it may be preferable toangle the entire the machine, or change the angle of the base of themachine body in a way to serve the function of suturing the targettissue.

As will be appreciated there are a variety of different suture materialsmay be used; these may range from 10/0 smallest to #2. Refer to thetables 1 and 2 for suture material and for needles used commercially.Regarding preferred size of needle, it depends on tissue type. Regardingsize of the device, overall width is preferably less than one inch,which is about the size of a basic suture width. Commercial device wouldbe preferably about ½ inch. Note that the most important dimensionrelating to the present invention is the diameter of the helico-spiralneedle spiral.

In other embodiments of the machines of the present invention, themachines are preloaded with a suture thread that is knotted at its firstend so that at the first stitch, the knot catches inside the tissue tobe stitched. Overall dimensions of the machine for automated suturing,particularly for disposable machines intended for single use applicationprovide for a machine height less than about one inch. A quick connectis preferred to attach the machine housing and functional components toa handle and motor shaft. Advantageously, the methods of the presentinvention provide for better cooptation of the wound; and this reducesthe chance of infection. If used for hollow organs, intestines, it willminimize leakage. Also note that it facilitates surgical suturing andminimizes the time of suturing. Speed is very important. The methods ofthe present invention are at least about twice as fast as manualsuturing methods.

In other embodiments of the present invention, preferably a guard isprovided to maintain the tissue to be sutured in a substantiallyedge-abutting position equal on both sides of the needle and hook regionof the machine; also preferably a separator at the front of thestitching area is provided, such as by way of example and notlimitation, a separator comprising a vertical plunger device ormechanism.

Certain modifications and improvements will occur to those skilled inthe art upon a reading of the foregoing description. The above-mentionedexamples are provided to serve the purpose of clarifying the aspects ofthe invention and it will be apparent to one skilled in the art thatthey do not serve to limit the scope of the invention. Applications toclose skin, muscles, fascia, hollow organs like intestines, bladder,etc. The device can be modified with an extended shaft such that it canbe used through a laparoscope in laparoscopic and robotic surgery. Notealso that the machine may be programmed by microprocessor, program,controlled by circuit board, timing controls and set of gears and microservos to coordinate all the motions to be fully automated andprogrammable.

Also, a footing mechanism with roller can be added to the base of thedevice where it comes in contact with the sutured tissue so as toadvance the machine in synchronized motion with the helico-spiralneedle. The roller mechanism can advance the device in relation to thesutured tissue at predetermined speed.

The base (footing) of the body of the machine (device) can be modifiedto allow the device to perform subcuticular skin suturing (inserting thesuture beneath the outer layer of the skin, parallel to the skinsurface). This is a standard surgical technique that is done, prior tothis art, manually by the surgeon to achieve cosmetic healing withminimal scarring. It is a tedious process and time consuming. Thisinvention makes this process speedy and consistently accurate.

To achieve the above-mentioned objectives, the footing (not shown) ofthe device that comes in contact with the skin surface is offset. Thus,the skin surfaces of the cut are offset, FIG. 4; with one side 52 higherthan the other side 53. Distance 50 in FIG. 4 represents this offset,which is equal to pitch of the helico-spiral needle, that is, thedistance 51 (the distance between the coils of the helico-spiralneedle).

As a result of the offsetting of the foot of the device, the skinsurface is also offset with equal distance as the device-footing offset.In an example embodiment, this distance is about 2 mm, which is theaverage thickness of the outer layer of the skin below which it isdesirable to insert the subcuticular skin sutures to achieve cosmeticresult with minimal scarring. When the helico-spiral needle starts itsturn stitch cycle, it first enters the subcutis on the edge 52 (FIG. 4)on the side of the wound that is higher, sideways tangential (parallel)with the skin surface and preferably perpendicular to the wound edge. Incases where the edge is not planar, the surgeon can make the appropriateentry such that the stitch will bring the tissue edges in properapposition. The needle continues its rotation beyond the 180 degrees,going lower while rotating until it exits the first side 52 and entersthe skin edge on the lower side of the wound 53 FIG. 5.

The needle completes a 360 degree rotation, exiting the left edge of thewound about 1 mm below the depth of the entry point, and continuesturning about 45 degrees to allow the vertical hook 22 FIG. 5 to pickthe suture loop up. The helico-spiral needle then reverses direction 405degrees backwards to return to its home base in the device housing, thuscompleting one stitch cycle. Thus, the helico-spiral needle rotates atleast about one and one-eighth turns. The whole device advances forwardto start another stitch cycle, the skin edges that have been suturedcome together in apposition with edge to edge adaptation and surface tosurface configuration that provides for cosmetically acceptable scarringas healing can occur without skin edges overlapping and the cutis is notdisturbed by sutures.

To further clarify the orientation of the device in relation to thewound, we consider the front of the wound, that area of the skin thathas not been sutured yet in front of the advancing device and the backof the wound is that area of the skin that has been sutured.

The footing of the device is flat (on the same plane) on both sidesbehind the area where the slanted surface ends and meets the flatsurface 54 FIG. 5. Thus the skin surface that has already been suturedand underneath this back part of the device housing, is on the sameplane without any offsetting, hence without skin edge overlap.

Another advantage of the subcuticular suturing technique is that thesuture material is hidden underneath the skin, thus leaving no skinmarks, compared to the standard skin stapling technique or other methodsof suturing whereas the suture material is exposed outside the skin. Thesubcuticular suture material that is proposed to be used by the deviceis absorbable by the body in few weeks (see Ethicon suture table 1) thusthere is no need to remove the suture later on. An example of suchsuture material is the mono-filament suture called Monocryl 5/0 (Ethicontrademark).

Also, keeping the suture material underneath the skin does minimize thechances of wound infection and it also eliminates the pain associatedwith removing the suture 7-10 days later on (such is the case when usingthe standard method of skin suturing). The patient also feels much lesspain associated with subcuticular suturing compared with the standardexposed sutures.

Note that the present invention provides for continuous suturing;however, the device does not move at constant speed when in use; so thenpreferred methods of the present invention provide for a visualindication showing when to move the device, and/or in automated versionsfor a machine, the machine is preferably programmed to move only whenthe needle is out of the tissue.

By way of example and not limitation, it is considered within the scopeof the present invention that the machines, methods, and needles may beadapted for stitching non-biologic material, or for non-medicalpurposes, such as stitching leather, artificial leather, etc. Thus, thedevice of the present invention can use different types of suturingmaterials to meet different needs. Also possible use of the device indifferent industries, such as by way of example and not limitation,veterinary medicine, textiles, automotive, industrial, and othermarkets. All modifications and improvements have been deleted herein forthe sake of conciseness and readability but are properly within thescope of the present invention.

The invention claimed is:
 1. A suture stitch configured to adjoin afirst and second inner edge of a tissue, including a top surface, asplit start, and a split end, in an inner edge-to-edge interface, thesuture stitch comprising: a suture material with at least one loopconfigured to be substantially parallel to the top surface and adjointhe first and the second inner edge; a suture knot acting as an anchorfor a first loop of the at least one loop; wherein the suture materialwith the at least one loop is configured to be subcuticular; wherein thesuture material with the at least one loop includes an additional loopthat double threads the at least one loop thus forming an outer loop andan inner loop, wherein the outer loop circumferentially contacts theinner loop as a discrete thread; and wherein the suture materialtraverses the diameter of a next loop of the at least one loop andconnects each subsequent loop via a connecting line of the suturematerial across each loop.
 2. The suture stitch of claim 1, wherein theat least one loop is substantially circular.
 3. The suture stitch ofclaim 1, wherein the inner loop and outer loop are substantiallycircular, concentric, and formed by looping the suture material onitself.
 4. A suture stitch configured to adjoin a first and second inneredge of a tissue, including a top surface, a split start, and a splitend, in an inner edge-to-edge interface, the suture stitch comprising asuture material; the suture material configured to connect the firstinner edge to the second inner edge; the suture material beingconfigured into at least one loop; the at least one loop being formedfrom an internal loop of the suture material being double threaded alongitself; the at least one loop being connected by at least two linearthreads of the suture material across the at least one loop's diameter;the at least two linear threads of the suture material being formed asan extension from the suture material that forms the at least one loop;the at least one loop having both a near stitched point and a farstitched point, wherein the far stitched point is opposite the nearstitched point; the near stitched point being the point on the at leastone loop configured to be closest to the split start; the at least oneloop configured to be parallel to the top surface; the at least one loopconfigured to be subcuticular; the at least one loop having a diameterbetween about 5 mm to 25 mm; a first loop of the at least one loopconfigured to be stitched coincident to the split start; the at leasttwo linear threads being formed into a knot at a first end; the firstend being tied to the first loop at the far stitched point; the at leasttwo linear threads being knottedly attached to the at least one loop atthe far stitched point.
 5. The suture stitch of claim 4, the at leastone loop having a diameter between about 5 mm and 15 mm.
 6. The suturestitch of claim 4, the at least two linear threads being knottedlyattached to the at least one loop, wherein the internal loop from theadditional loop is threaded between the at least two linear threads. 7.The suture stitch of claim 4, the suture material extending from thefirst loop to form a second loop.
 8. The suture stitch of claim 7, thesuture material being extended below the at least two linear threads.